This 60-minute webinar is designed to help clinical research, regulatory affairs, and GCP quality professionals decode the complexities of the updated guidance. The speaker breaks down the key shifts, themes, and differences between R2 and R3, provides real-world examples to simplify the changes, and introduces a framework to help identify gaps and prioritize the next steps for compliance.
This exciting webinar was led by an inspiring patient advocate and voice for the community as she discussed how to build awareness, strategies, and the idea of technical empathy and how we all can benefit.
This interactive webinar reflected on the need for culturally competent research and advocacy, the complexity of the Latinx identity, and the need to reflect on how we relate to the Latine identity.
In the final session of the series, focus shifted to provisions designed to protect all parties from potential liabilities while fostering a safer trial environment. Topics included indemnification and letters of indemnification, subject injury, and insurance.
In part two of the series, attendees had the opportunity to hear from clinical trial attorneys as they shared insights on critical regulatory issues that can impact the trial’s legality. This session covered Medicare billing, Anti-Kickback Statute and the Personal Services Safe Harbor, and privacy.